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Regulatory considerations in oncologic biosimilar drug development
Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Taylor & Francis
2015
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622730/ https://www.ncbi.nlm.nih.gov/pubmed/25961747 http://dx.doi.org/10.1080/19420862.2015.1040973 |